Even as the lab testing market grows, too many tests escape FDA review based on a meaningless categorization that has nothing to do with patient safety. Congress should pass the VALID Act of 2021, allowing the FDA to adequately regulate direct-to-consumer and other lab tests with the potential to harm the public.
Trump administration announces some COVID-19 tests can skip FDA review, providing new opportunities for dubious lab tests
The Trump administration unexpectedly announced that the FDA will no longer regulate some lab tests, including those for COVID-19. In addition to potentially allowing unreliable COVID tests on the market, the decision creates an opening for more bogus CAM tests.
Experts review the evidence and find that common CAM lab tests have "little or no clinical benefit" and are "a potential risk to patient safety." Regulatory reform is urgently needed to protect the public.
The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it...